FDA Extends Review Period For Eurand’ Zenpep

Eurand has reported that FDA has extended the June 2009 user fee goal date for the New Drug Application for Zenpep, by three months.

Zenpep is a proprietary pancreatic enzyme product developed for the treatment of exocrine pancreatic insufficiency.

FDA did not request the company to provide any further information, but attributed the reason for the delay to the need for additional time to review the current submission.

Eurand is a specialty pharmaceutical company that develops, manufactures and commercializes pharmaceutical and biopharmaceutical products based on its proprietary pharmaceutical technologies. Eurand has had five products approved by the FDA since 2001, and has a pipeline of product candidates in development for itself and its collaboration partners.